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Industry lobbyists have wrecked plans to overhaul safety regulations for medical devices in Europe, report Simon Bowers, Deborah Cohen, and colleagues from the International Consortium of Investigative Journalists. Meanwhile, confidential injury and malfunction reports have tripled in less than 10 years in many European countries

For the past decade, European lawmakers have been at the centre of a lobbying storm. Bold plans to overhaul safety regulations for the millions of medical implants embedded in patients each year—including artificial hips, breast implants, stents, defibrillators, and pacemakers—have been wrecked by an army of lobbyists.

An investigation by the International Consortium of Investigative Journalists and its partner news organisations, including The BMJ, has discovered how top EU politicians and officials were won over by misleading claims from implant industry lobby groups.

These claims had a pivotal role in shaping the course of EU policy and killing off any prospect of a fundamental strengthening of medical device regulation, first in the European Commission and later in the European parliament.

Public health campaigners say Europe is in urgent need of tougher rules. Even though millions of Europeans’ lives have been lengthened or improved by medical devices, the EU has borne the brunt of many of the world's worst implant scandals, unnecessarily leaving many patients scarred, in pain, or even dead. Leading surgeons, regulators, lawyers, and campaigners have said Europe’s approach to evaluating and approving new implants means that its citizens are treated “like guinea pigs.”123

The Implant Files is a year long investigation into the behaviours of the medical device industry. The investigation was coordinated by ICIJ, involving more than 250 journalists from 36 countries, in the UK including The BMJ, BBC Panorama, and the Guardian. It traces rapid advances in device technology and reveals that safety regulations have …